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Safety & Efficacy

Gastric Banding Was Shown to Be Safer Than Sleeve and RYGB1-6

Laparoscopic adjustablegastric banding

Performed laparoscopically, a saline-filled band is placed around the top of the stomach. There is no stomach amputation or cutting of the intestines during this procedure.7

Designed for long-term use. Can be removed and reversed if desired.7

Can be adjusted over time to fit the needs of the patient.7

Laparoscopic sleevegastrectomy

Performed laparoscopically, more than 80% of the stomach is amputated to create a sleeve.8,9

A more radical procedure than a gastric band that is permanent and irreversible.9

Cannot be adjusted.9

Roux-en-ygastric bypass

Performed either open or laparoscopically, the stomach is cut and the intestines rerouted to bypass significant digestion.7

Extremely difficult to reverse.7

Cannot be adjusted.7

Based on a recent analysis of the BOLD™*, ACS†, and LABS‡ databases, LAGB demonstrated the following vs Sleeve and RYGB:

Laparoscopic adjustible gastric banding

Roux-en-y gastrick bypass

Laparoscopic sleeve gastrectomy

Total Complications

6%

18%

24%

Reoperation Rate

1%

3%

5%

Readmission Rate

2%

5%

6%

30-Day Morbidity

1%

6%

6%

Early Major Complications

1%

NA

5%

Mean Length of Stay

< 1 day

~3 days

~3 days

Improved or resolved comorbidities of obesity following weight loss with LAGB

* The LAP-BAND® System was approved in the United States on the basis of a nonrandomized, single-arm study (N=299). Significant improvement in percent of excess weight loss vs baseline was achieved at 12 months (34.5%), 24 months (37.8%), and 36 months (36.2%).

† Year-1 data from Allergan's LBMI pivotal study is based on a complete database of 143 obese adults with a Month-12 visit. The currently available Year-2 results are based on a database snapshot of an incomplete data set that has not been source verified. These data were reviewed by FDA in support of the recently approved LAP-BAND® label expansion in the United States.

‡ Data based on interim analysis of ongoing LAP-BAND AP® trial.

LAP-BAND® SYSTEM has been proven to provide significant weight loss within the first 1-2 years.

– LAP-BAND® SYSTEM was shown to provide 52% excess weight loss at 2 years, in an ongoing clinical study of people with a BMI of 35 or above.14

– In a separate study, LAP-BAND® SYSTEM was shown to provide 65% excess weight loss at 1 year and 70% excess weight loss at 2 years for people with a BMI between 30 and 40. That translates into shrinking an average of 6 inches off the waistline and 6 inches off the hips.*15, 16

LAP-BAND® SYSTEM can help provide weight loss that lasts.

– In a long-term study, severely obese patients lost an average of 60% of their excess weight 5 years after the LAP-BAND® System procedure.17

*The Bariatric Outcomes Longitudinal Database™ (BOLD™) was developed to help ensure ongoing compliance with the American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Surgery Center of Excellence (BSCOE) program and develop general knowledge about optimal bariatric surgery practices. This analysis of the BOLD™ database includes data from 57,918 patients.†The American College of Surgeons Bariatric Surgery Center Network (ACS-BSCN) database was developed as part of the ACS-BSCN accreditation program. This analysis of the ACS database includes data from 28,616 patients.‡The Longitudinal Assessment of Bariatric Surgery (LABS) is an observational study of 30-day outcomes in consecutive bariatric surgery patients at 10 clinical sites in the United States. This analysis of the LABS database includes data from 4776 patients.§Adverse outcomes include death; deep-vein thrombosis or venous thromboembolism; reintervention with the use of a percutaneous, endoscopic, or operative technique; or failure to be discharged from the hospital within 30 days after surgery.||Year-1 data from Allergan's LBMI pivotal study is based on a complete database of 143 obese adults with a Month-12 visit. The currently available Year-2 results are based on a database snapshot of an incomplete data set that has not been source verified. These data were reviewed by the FDA in support of the recently approved LAP-BAND® label expansion in the United States.

Search for a LAP-BAND® Specialist near you

Have a question? Need more information? 1-800-LAP-BAND The LAP-BAND® System Information Hotline is available 7 days a week.

Important LAP-BAND® System Safety Information

Indications: The LAP-BAND® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity-related comorbid conditions.

It is indicated for use only in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.

Contraindications: The LAP-BAND® System is not recommended for non-adult patients, patients with conditions that may make them poor surgical candidates or increase the risk of poor results (e.g., inflammatory or cardiopulmonary diseases, GI conditions, symptoms or family history of autoimmune disease, cirrhosis), who are unwilling or unable to comply with the required dietary restrictions, who have alcohol or drug addictions, or who currently are or may be pregnant.

Warnings: The LAP-BAND® System is a long-term implant. Explant and replacement surgery may be required. Patients who become pregnant or severely ill, or who require more extensive nutrition may require deflation of their bands. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion.

Adverse Events: Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure, and the patient's ability to tolerate a foreign object implanted in the body.

Band slippage, erosion and deflation, reflux, obstruction of the stomach, dilation of the esophagus, infection, or nausea and vomiting may occur. Reoperation may be required.

Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.

Important: For full safety information please click here, talk with your doctor, or call Apollo Customer Support at 1-855-551-3123.

National Quality Measures Clearinghouse. Adult body mass index (BMI) assessment:
percentage of members 18 to 74 years of age who had an outpatient visit and who had their BMI documented during the measurement year or the year prior to the measurement year.

Hutter MM, Schirmer BD, Jones DB, et al. First report from the American College of Surgeons Bariatric Surgery Center Network—laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann Surg. 2011; 254:410-422.